Clinical Research Associate

A-SPINE

Clinical Research Associate supporting clinical trials and regulatory submissions for Kuros Biosciences. Overseeing study tracking tools and ensuring compliance with clinical regulations.

Posted 5/12/2026full-timeRemote • Alaska, Arizona, California, Colorado, Hawaii, Idaho, Iowa, Kansas, Louisiana, Montana, Nevada, New Mexico, New York, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wyoming • 🇺🇸 United StatesJuniorMid-Level💰 $65,000 - $75,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee the management and tracking of clinical trial data to ensure accuracy, integrity, and completeness.
Conduct site qualification visits, site monitoring visits, and study close-out visits. Provide support to site staff during audits or inspections.
Ensure clinical trials are conducted in compliance with protocols, Good Clinical Practice (GCP), ICH guidelines, SOPs, and regulatory standards (FDA/DEA).
Review and manage electronic Case Report Forms (eCRFs), ensuring data is accurate and aligned with study protocols.
Assist in the development and maintenance of Case Report Forms (CRFs) and other study-related documents.
Provide training to site personnel on study procedures, protocols, and regulatory requirements.
Regularly review data entered into the Electronic Data Capture (EDC) system to ensure compliance with study protocols.
Identify, address, and escalate any study-related risks, issues, or opportunities for improvements.
Follow up with clinical sites to ensure that data collection is progressing as planned and all required documentation is completed.
Ensure timely and accurate management of regulatory documents and maintain compliance with regulatory requirements.
Engage with Key Opinion Leaders (KOLs) in the medical and research communities to stay informed on scientific research and clinical data.
Stay up-to-date with the latest developments in scientific research and clinical data relevant to Kuros Biosciences.
Review and track clinical trial-related invoices, ensuring accuracy and compliance.
Contribute to the creation and maintenance of project plans for clinical trials, ensuring alignment with company policies and timelines.
Work independently to complete tasks while ensuring alignment with team objectives, timelines, and expectations.
Expected to travel 3-5 days per month for site visits and clinical trial support.

Requirements

What you’ll need

Bachelor’s Degree in a life sciences field (science-related discipline preferred).
Minimum 3 years of medical device industry experience.
Experience in conducting clinical trials, both as a sponsor and/or CRO, with on-site monitoring experience required.
The highest ethical standards, specifically surrounding protected medical information and clinical research.
Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice, ICH, ISO, FDA, and the MedTech EU Code of Practice.
Excellent verbal and written communication skills (protocols, reports, correspondence, etc.).

Benefits

Comp & perks

Health insurance
Flexible working hours
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementdata integrityelectronic Case Report Forms (eCRFs)Case Report Forms (CRFs)Electronic Data Capture (EDC)site monitoringregulatory document managementproject planningdata collectionrisk management

Soft Skills

communication skillstrainingindependenceteam alignmentproblem-solvingattention to detailethical standardscollaborationorganizational skillsadaptability

Certifications

Bachelor’s Degree in life sciences